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Regulation (EU) 2015/2283 of the European Parliament and of the CouncilShow full title
Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (Text with EEA relevance)
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Article 28U.K.Authorisation procedure in case of a parallel application for the authorisation of a health claim
1.The [F1appropriate authority must], on request by the applicant, stay an authorisation procedure for a novel food started following an application, where the applicant has submitted:
(a)a request for data protection in accordance with Article 26; and
(b)an application for the authorisation of a health claim on the same novel food in accordance with Article 15 or 18 of Regulation (EC) No 1924/2006, in conjunction with a request for data protection in accordance with Article 21 of that Regulation.
The stay of the authorisation procedure shall be without prejudice to the assessment of the food by the [F2Food Safety Authority] in accordance with Article 11.
2.The [F1appropriate authority must] inform the applicant about the date of effect of the stay.
3.While the authorisation procedure is stayed, time shall cease to run for the purposes of the time-limit laid down in Article 12(1).
4.The authorisation procedure shall resume when [F3the opinion has been received] on the health claim pursuant to Regulation (EC) No 1924/2006.
The [F1appropriate authority must] inform the applicant about the date of resumption of the authorisation procedure. From the date of resumption, time shall begin to run afresh from the beginning for the purposes of the time-limit laid down in Article 12(1) of this Regulation.
5.In the cases referred to in paragraph 1 of this Article, where data protection has been granted in accordance with Article 21 of Regulation (EC) No 1924/2006, the period of data protection granted in accordance with Article 26 of this Regulation shall not exceed the period of data protection granted in accordance with Article 21 of Regulation (EC) No 1924/2006.
6.The applicant may withdraw at any time the request for staying the authorisation procedure submitted in accordance with paragraph 1. In that case, the authorisation procedure shall resume and paragraph 5 shall not apply.
Textual Amendments
F1Words in Art. 28 substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 34(a) (as substituted by S.I. 2020/1504, regs. 1(2), 15(10)); 2020 c. 1, Sch. 5 para. 1(1)
F2Words in Art. 28(1) substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 34(b) (as substituted by S.I. 2020/1504, regs. 1(2), 15(10)); 2020 c. 1, Sch. 5 para. 1(1)
F3Words in Art. 28(4) substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, reg. 34(c) (as substituted by S.I. 2020/1504, regs. 1(2), 15(10)); 2020 c. 1, Sch. 5 para. 1(1)
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